- Email: [email protected]
Randomized Controlled Trial on the Skin Toxicity of Panitumumab in Third Line Treatment of Kras Wild-Type Metastatic Colorectal Cancer: Hgcsg1001 (Japanese Skin Toxicity Evaluation Protocol with Panitumumab: J-Stepp): Additional Analysis of Qol and Skin Toxicity
Annals of Oncology 25 (Supplement 4): iv167–iv209, 2014 doi:10.1093/annonc/mdu333.54
552P
Pharmaceutical, Eli Lilly Japan, Kureha Corporation. All other authors have declared no conflicts of interest.
M. Nakamura1, Y. Kobayashi2, S. Yuki3, H. Nakatsumi3, H. Hayashi3, I. Iwanaga4, Y. Tsuji5, K. Hatanaka6, H. Okuda7, J. Konno8, F. Yamamoto9, K. Iwai10, M. Onodera11, T. Takagi12, H. Hisai13, M. Koike14, R. Abe15, K. Oba16, Y. Sakata17, Y. Komatsu18 1 Gastroenterology, Sapporo City General Hospital, Sapporo, JAPAN 2 Internal Medicine, Kushiro Rosai Hospital, Kushiro, JAPAN 3 Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, JAPAN 4 Gastroenterology, Japanese Red Cross Kitami Hospital, Kitami, JAPAN 5 Medical Oncology, Tonan Hospital, Sapporo, JAPAN 6 Gastroenterology, Hakodate Municipal Hospital, Hakodate, JAPAN 7 Medical Oncology, Keiyukai Sapporo Hospital, Sapporo, JAPAN 8 Gastroenterology, Hakodate Central General Hospital, Hakodate, JAPAN 9 Gastroenterology, Tomakomai City Hospital, Tomakomai, JAPAN 10 Surgery, Oji General Hospital, Tomakomai, JAPAN 11 Gastroenterology, Abashiri Kosei General Hospital, Abashiri, JAPAN 12 Gastroenterology, Sapporo Hokushin Hospital, Sapporo, JAPAN 13 Gastroenterology, Date Red Cross Hospital, Date, JAPAN 14 Surgery, KKR Sapporo Medical Center, Sapporo, JAPAN 15 Dermatology, Hokkaido University Graduate School of Medicine, Sapporo, JAPAN 16 Translational Research and Clinical Trial Center, Hokkaido University Hospital, Sapporo, JAPAN 17 Misawa City Hospital, Misawa, JAPAN 18 Cancer Center, Hokkaido University, Sapporo, JAPAN
Aim: Panitumumab (Pmab) has demonstrated efficacy in patients with KRAS wild-type metastatic colorectal cancer (mCRC). Although the STEPP study (Lacouture M. E. et al. J Clin Oncol. 2010; 28: 1351-7.) showed that pre-emptive skin treatment reduced skin toxicities compared with reactive treatment among patients receiving Pmab, data for Asians has not been reported. We planned a randomized, open-label trial to verify the differences between pre-emptive and reactive treatment for skin toxicities in Japanese patients. Methods: Patients receiving third-line Pmab-containing regimens for mCRC were randomly assigned 1:1 to pre-emptive (skin moisturizers, sunscreen, topical steroid, and minocycline) or reactive (only skin moisturizers) skin treatment. The primary endpoint was the cumulative incidence of ≥grade 2 skin toxicities during the 6-week treatment period. Retrospectively, a dermatologist reviewed skin toxicities, in a blinded manner, using photographs. Results: Of 95 enrolled patients, 47 were assigned to pre-emptive, and 48 to reactive treatment. The incidence of ≥grade 2 skin toxicities during the 6-week treatment period (investigators’ assessment) was 21.3% and 62.5% (risk ratio [RR], 0.34; 95% CI, 0.19 to 0.62; P < 0.001) for the pre-emptive and reactive treatment groups, respectively. A similar trend was observed in central review (18.6% and 50.0%, respectively [RR, 0.37; 95% CI, 0.19 to 0.74; P = 0.002]). There were no statistical differences in QOL assessed by using the DLQI (Dermatology Life Quality Index) in slope (P = 0.832), at 3 weeks (P = 0.222), at 7 weeks (P = 0.243), and 13 weeks (P = 0.874). Conclusions: Although pre-emptive skin treatment could not be affected with QOL, it could reduce the severity of skin toxicities during Pmab treatment. Our data clearly validate that pre-emptive treatment can also be recommended in Japanese patients. Disclosure: M. Nakamura: Takeda Pharmaceutical, Chugai Pharmaceutical, Bayer Yakuhin; S. Yuki: Taiho Pharmaceutical, Chugai Pharmaceutical, Bristol-Myers Squibb, Merck Serono, Takeda Pharmaceutical, Yakult Honsha; Y. Sakata: Taiho Pharmaceutical, Daiichi Sankyo, Yakult Honsha, Otsuka Pharmaceutical, Merck Serono, Bristol-Myers Squibb, Synergy International; Y. Komatsu: Yakult Honsha, Taiho Pharmaceutical, Chugai Pharmaceutical, Merck Serono, Pfizer Japan, Novartis Pharma, Sawai Pharmaceutical, Ono Pharmaceutical, Daiichi Sankyo, Takeda
© European Society for Medical Oncology 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_4/iv189/2241325 by guest on 25 October 2019
RANDOMIZED CONTROLLED TRIAL ON THE SKIN TOXICITY OF PANITUMUMAB IN THIRD LINE TREATMENT OF KRAS WILD-TYPE METASTATIC COLORECTAL CANCER: HGCSG1001 (JAPANESE SKIN TOXICITY EVALUATION PROTOCOL WITH PANITUMUMAB: J-STEPP): ADDITIONAL ANALYSIS OF QOL AND SKIN TOXICITY
abstracts
gastrointestinal tumours, colorectal
552P
Pharmaceutical, Eli Lilly Japan, Kureha Corporation. All other authors have declared no conflicts of interest.
M. Nakamura1, Y. Kobayashi2, S. Yuki3, H. Nakatsumi3, H. Hayashi3, I. Iwanaga4, Y. Tsuji5, K. Hatanaka6, H. Okuda7, J. Konno8, F. Yamamoto9, K. Iwai10, M. Onodera11, T. Takagi12, H. Hisai13, M. Koike14, R. Abe15, K. Oba16, Y. Sakata17, Y. Komatsu18 1 Gastroenterology, Sapporo City General Hospital, Sapporo, JAPAN 2 Internal Medicine, Kushiro Rosai Hospital, Kushiro, JAPAN 3 Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, JAPAN 4 Gastroenterology, Japanese Red Cross Kitami Hospital, Kitami, JAPAN 5 Medical Oncology, Tonan Hospital, Sapporo, JAPAN 6 Gastroenterology, Hakodate Municipal Hospital, Hakodate, JAPAN 7 Medical Oncology, Keiyukai Sapporo Hospital, Sapporo, JAPAN 8 Gastroenterology, Hakodate Central General Hospital, Hakodate, JAPAN 9 Gastroenterology, Tomakomai City Hospital, Tomakomai, JAPAN 10 Surgery, Oji General Hospital, Tomakomai, JAPAN 11 Gastroenterology, Abashiri Kosei General Hospital, Abashiri, JAPAN 12 Gastroenterology, Sapporo Hokushin Hospital, Sapporo, JAPAN 13 Gastroenterology, Date Red Cross Hospital, Date, JAPAN 14 Surgery, KKR Sapporo Medical Center, Sapporo, JAPAN 15 Dermatology, Hokkaido University Graduate School of Medicine, Sapporo, JAPAN 16 Translational Research and Clinical Trial Center, Hokkaido University Hospital, Sapporo, JAPAN 17 Misawa City Hospital, Misawa, JAPAN 18 Cancer Center, Hokkaido University, Sapporo, JAPAN
Aim: Panitumumab (Pmab) has demonstrated efficacy in patients with KRAS wild-type metastatic colorectal cancer (mCRC). Although the STEPP study (Lacouture M. E. et al. J Clin Oncol. 2010; 28: 1351-7.) showed that pre-emptive skin treatment reduced skin toxicities compared with reactive treatment among patients receiving Pmab, data for Asians has not been reported. We planned a randomized, open-label trial to verify the differences between pre-emptive and reactive treatment for skin toxicities in Japanese patients. Methods: Patients receiving third-line Pmab-containing regimens for mCRC were randomly assigned 1:1 to pre-emptive (skin moisturizers, sunscreen, topical steroid, and minocycline) or reactive (only skin moisturizers) skin treatment. The primary endpoint was the cumulative incidence of ≥grade 2 skin toxicities during the 6-week treatment period. Retrospectively, a dermatologist reviewed skin toxicities, in a blinded manner, using photographs. Results: Of 95 enrolled patients, 47 were assigned to pre-emptive, and 48 to reactive treatment. The incidence of ≥grade 2 skin toxicities during the 6-week treatment period (investigators’ assessment) was 21.3% and 62.5% (risk ratio [RR], 0.34; 95% CI, 0.19 to 0.62; P < 0.001) for the pre-emptive and reactive treatment groups, respectively. A similar trend was observed in central review (18.6% and 50.0%, respectively [RR, 0.37; 95% CI, 0.19 to 0.74; P = 0.002]). There were no statistical differences in QOL assessed by using the DLQI (Dermatology Life Quality Index) in slope (P = 0.832), at 3 weeks (P = 0.222), at 7 weeks (P = 0.243), and 13 weeks (P = 0.874). Conclusions: Although pre-emptive skin treatment could not be affected with QOL, it could reduce the severity of skin toxicities during Pmab treatment. Our data clearly validate that pre-emptive treatment can also be recommended in Japanese patients. Disclosure: M. Nakamura: Takeda Pharmaceutical, Chugai Pharmaceutical, Bayer Yakuhin; S. Yuki: Taiho Pharmaceutical, Chugai Pharmaceutical, Bristol-Myers Squibb, Merck Serono, Takeda Pharmaceutical, Yakult Honsha; Y. Sakata: Taiho Pharmaceutical, Daiichi Sankyo, Yakult Honsha, Otsuka Pharmaceutical, Merck Serono, Bristol-Myers Squibb, Synergy International; Y. Komatsu: Yakult Honsha, Taiho Pharmaceutical, Chugai Pharmaceutical, Merck Serono, Pfizer Japan, Novartis Pharma, Sawai Pharmaceutical, Ono Pharmaceutical, Daiichi Sankyo, Takeda
© European Society for Medical Oncology 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_4/iv189/2241325 by guest on 25 October 2019
RANDOMIZED CONTROLLED TRIAL ON THE SKIN TOXICITY OF PANITUMUMAB IN THIRD LINE TREATMENT OF KRAS WILD-TYPE METASTATIC COLORECTAL CANCER: HGCSG1001 (JAPANESE SKIN TOXICITY EVALUATION PROTOCOL WITH PANITUMUMAB: J-STEPP): ADDITIONAL ANALYSIS OF QOL AND SKIN TOXICITY
abstracts
gastrointestinal tumours, colorectal